Cleared Traditional

K921183 - DIASTAT ANTI-MITOCHONDRIAL ANTIBODY KIT

K921183 is an FDA 510(k) clearance for DIASTAT ANTI-MITOCHONDRIAL ANTIBODY KIT, manufactured by Shield Diagnostics, Ltd.. The device is a Class 2 Immunology device with product code DBM cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K921183 · Shield Diagnostics, Ltd. · Immunology device
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Jun 1992
Decision
102d
Days
Class 2
Risk

K921183 is an FDA 510(k) clearance for the DIASTAT ANTI-MITOCHONDRIAL ANTIBODY KIT. Classified as Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control (product code DBM), Class II - Special Controls.

Submitted by Shield Diagnostics, Ltd. (Dundee, GB). The FDA issued a Cleared decision on June 19, 1992 after a review of 102 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5090 - the FDA immunology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Shield Diagnostics, Ltd. devices

FDA 510(k) Submission Details - K921183

510(k) Number K921183 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 1992
Decision Date June 19, 1992
Days to Decision 102 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 105d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DBM Device Classification - Class 2, Special Controls

Product Code DBM Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5090
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.

Regulatory Peers - DBM Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control

All 18
Devices cleared under the same product code (DBM) and FDA review panel - the closest regulatory comparables to K921183.
HY-TEC/MANUAL AUTOIMMUNE KIT FOR MITOCHONDRIA
K962452 · Hycor Biomedical, Inc. · Nov 1996
VARELISA M2 ANTIBODIES
K945607 · Elias U.S.A., Inc. · Jan 1995
AYNELISA M2-ANTIBODIES
K930143 · Elias U.S.A., Inc. · May 1993
AUTOANTIBODY SCREEN TEST SYSTEM
K831358 · Zeus Scientific, Inc. · Jun 1983
KALLESTAD HEP-2 CELL LINE SUBSTRATE
K810863 · Kallestad Laboratories, Inc. · Apr 1981
AFT TM SYSTEM ANTIMITOCHONDRIAL ANTIBODY
K800821 · Calbiochem-Behring Corp. · Apr 1980